# K200133: hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream

- Pathway: 510(k) (Traditional)
- Applicant: Safecare Biotech (Hangzhou) Co., Ltd.
- Decided: Aug 13, 2020 after 205 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K941090 (1994). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043443: One Step HCG Urine Pregnancy Test, Guangzhou Wondfo Biotech Co., Ltd. (2005) Summary page 4.

## Most influential descendants
- K240242: HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) (2024), 0 descendants of its own

## Indications for use
The hCG Urine Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. The hCG Urine Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. The hCG Urine Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.

Source page: https://510kreport.com/device/K200133
Methodology: https://510kreport.com/methodology